achieve compliance, reduce risk, enhance safety
Rapid eDHR Solution
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Electronic Device History Record (eDHR)
An electronic device history record (eDHR) allows manufacturers to collect and manage critical records required by the FDA to document the production of each device. By automating your device history record processes with an eDHR, you can more confidently achieve compliance with FDA cGMP requirements, reduce risk, and enhanced safety for medical device users. By bringing together all data about a device’s manufacturing and testing history, the eDHR tracks data to ensure the document process and compliance was followed. That includes the requirement that the components and materials approved for assembly into the product were the ones actually used, all tests passed, and that all workers involved in the manufacturing and testing processes were trained and certified on the required operations.
The Fastest, Easiest Way to Launch eDHR Quality Records
With the Rapid eDHR solution, you can jump-start your electronic record-keeping and begin to see advantages at your next compliance audit. The Rapid eDHR offering is part of the 42Q Cloud platform: a complete, scalable Cloud solution for managing global manufacturing operations.
eDHR Includes:
• Tracking and Traceability
• Online Work Instructions
• Employee Verification
• 42Q Live and Operations Dashboard
• Standard Reports & Cycle Time Report
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Our Customers Deploy in as Little as 6 Weeks
Our deployment services team is certified in our RPM (Rapid Production Model) implementation methodology and will guide you through a timely and effective deployment of 42Q.